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  • Transcatheter Aortic Valve Implantation
  • Procedure & Performance
  • Clinical Evidence
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  • Treating ssAS

    • Precision

    Facilitate implant depth accuracy. 

    The cusp overlap view isolates the noncoronary cusp and elongates the left ventricular outflow tract. This provides a greater visual separation between the basal annular plane and the conduction system, and an accurate patient-specific anatomical view to assess and achieve target implant depth.1

    Control

    Predictable valve deployment 

    Slow deployment starting from a supra-annular position allows the valve to descend to its target position, providing users with control over valve deployment and requiring minimal catheter manipulation. This minimizes the risk of interaction with the conduction system.

    Optimize PRO FX Addendum analysis2

    The cusp overlap technique with an optimized care pathway continues to show dependable clinical outcomes.†

    Accuracy when it matters most

    • Reproducible single-digit pacemaker rate: 6.7% PPI at 30 days
    • No ≥ moderate PVL (91% none/trace) at discharge 
    • 1 day median discharge
    • No patient-prosthesis mismatch (PPM) in > 93% of patients at discharge

    Devices used: 100% Evolut™ FX. This is an expanded analysis of the Optimize PRO study of 146 patients receiving only the Evolut™ FX valve.

    † This is an interim analysis of 400 main cohort patients. At the conclusion of the study, more than 650 patients will have been evaluated.

    Real-world accuracy

    Accurate depth assessment at the noncoronary cusp (NCC), facilitated with the cusp overlap technique, has resulted in single-digit pacemaker rates in several single-center and multicenter clinical studies.

    Single-digit new 30-day permanent pacemaker implantation rates

    • 1.5%
      Study 1
      (n = 65)3
    • 5.2%
      Study 2
      (n = 134)4
    • 5.7%‡
      Study 3
      (n = 105)5
    • 4.6%
      Study 4
      (n = 87)6
    • 6.4%
      Study 5
      (n = 156)7
    • 6.7%
      Study 6
      (n = 151)2

    Excludes patients with baseline implantable cardioverter defibrillator or pacemaker.

    ‡ Discharge rates.

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